Most dental schools have a Dental
Research Administration (DRA) to promote and assist students, residents and
faculty on how to properly develop and conduct research studies at the schools.
The DRA helps researchers work through the requirements of the school’s
Institutional Review Board (IRB). Last year, the Department of Health and Human
Services (HHS), along with 15 other federal agencies revised,
the protections for research study and clinical trial participants for the
first time in nearly 30 years. The Federal Policy for the Protection of Human
Subjects, referred to as the Common
Rule, was supposed to take effect this summer but was delayed, in
part, until Jan. 21, 2019.
In the meantime, dental institutions
have the option to implement for certain research three provisions of the 2018 requirements.
The three provisions are (1) The revised definition of ”research,” which deems
certain activities not to be research covered by the Common Rule; (2) the elimination
of the requirement for annual continuing review with respect to certain
categories of research; and (3) the elimination of the requirement that IRBs
review grant applications or other funding proposals related to the research. Dental
that conduct human research will have substantial work in educating researchers
and advisors. Some of the required changes will rely upon guidance and updates
that the Office for Human Research Protections has yet to provide, such as
guidance on consent.